Inova Diagnostics, Inc.
FDA 510(k) & PMA Approved Devices — 16 products
Total Devices16
Categories11
Latest Approval2026-02-06
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K243979 | Aptiva APS IgA Reagent | MSV | 2026-02-06 | View |
| 510(k) | K223093 | Aptiva APS IgG Reagent; Aptiva APS IgM Reagent | MID | 2024-12-17 | View |
| 510(k) | K213403 | Aptiva CTD Essential Reagent | LLL | 2023-09-29 | View |
| 510(k) | K200230 | Aptiva Celiac Disease IgG Reagent | MVM | 2021-08-26 | View |
| 510(k) | K193604 | Aptiva Celiac Disease IgA Reagent | MVM | 2021-06-16 | View |
| 510(k) | K192916 | NOVA Lite DAPI dsDNA Crithidia luciliae Kit | KTL | 2020-12-11 | View |
| 510(k) | K190088 | QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents | DHR | 2019-04-17 | View |
| 510(k) | K180971 | QUANTA Flash Calprotectin and Fecal Extraction Device | NXO | 2018-10-16 | View |
| 510(k) | K180975 | QUANTA Flash HMGCR Reagents | LLL | 2018-06-25 | View |
| 510(k) | K170993 | QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer | NXO | 2017-12-22 | View |
| 510(k) | K163538 | QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls | NBS | 2017-09-06 | View |
| 510(k) | K163525 | QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls | DBM | 2017-09-05 | View |
| 510(k) | K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit | MOB | 2017-02-03 | View |
| 510(k) | K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | LLL | 2016-06-01 | View |
| 510(k) | K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | LSW | 2016-04-11 | View |
| 510(k) | K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | LLL | 2016-02-12 | View |
No matching devices.